BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTXIDE2

    MDR report key: 11819405 · Received May 13, 2021

    Report

    Report Number
    1222993-2021-00011
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 13, 2021
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHIN 5 MINUTES OF TREATMENT, PATIENT COMPLAINED OF NOT FEELING WELL AND NAUSEA. VITALS WERE CONFIRMED TO BE STABLE AND PATIENT THEN COMPLAINED OF EPIGASTRIC AND CHEST TIGHTNESS. PARAMEDICS WERE THEN CALLED. EKG AND ORTHOSTATICS WERE PERFORMED AND RESULTS WERE CONFIRMED NORMAL. PATIENT WAS THEN SENT TO THE ER FOR FURTHER EVALUATION. WHILE IN THE ER, A VAGINAL EXAM WAS PERFORMED UNDER ANESTHESIA AND RESULTS SHOWED NO PERFORATION. FLEXIBLE SIGMOIDOSCOPY RULED OUT RECTAL PERFORATION. TREATMENT WAS PERFORMED WITHIN NORMAL LIMITS. THIS INCIDENT IS DETERMINED TO BE INCONCLUSIVE. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING WITHIN SPECIFICATION. THIS EVENT IS REPORTABLE BECAUSE THE PATIENT WAS DIAGNOSED WITH SEVERE PNEUMOPERITONEUM. HOWEVER, THE ROOT CAUSE IS INCONCLUSIVE BECAUSE THERE WERE NO PERFORATIONS AND DEVICE WAS FOUND TO BE OPERATING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    5 MINUTES INTO TREATMENT PATIENT WAS NOT FEELING WELL AND PARAMEDICS WERE CALLED AND PATIENT WAS TAKEN TO EMERGENCY ROOM. PATIENT WAS DIAGNOSED WITH SEVERE PNEUMOPERITONEUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713443 SMARTXIDE2 SMARTXIDE2 GEX EL. EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other